The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This...
The documents present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the legislation. Read the news published by DG Health and...
Today, the Accelerating Clinical Trials in the EU (ACT EU) initiative, jointly run by the European Commission, European Medicines Agency and Heads of Medicines Agencies of the Member States, is publishing new draft guidance on the...
This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 6, Manufacture of Medicinal Gases, of the Good Manufacturing Practice (GMP) guide, that is common to the...
This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 15, Qualification and validation, of the Good Manufacturing Practice (GMP) guide, that is common to the Member...
EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle. The principles give broad guidance on AI use in evidence generation...
The EMA recently issued an Explanatory note on the withdrawal of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU. The interim guidance focused on the requirements for annual enhanced...
In certain circumstances, a medical device or in vitro diagnostic medical device may be described as a breakthrough device when it represents an innovation that is expected, based on available information, to offer a novel...
This guidance is applicable to all medical devices and in vitro diagnostic medical devices. The main objectives of this guidance are to describe: the post-market surveillance (PMS) system and the PMS plan, the main activities...
This reflection paper aims to provide an overview of the scientific and regulatory considerations for non-human primate use in safety testing of human medicinal products. It highlights the existing flexibility within published guidelines to incorporate...
